31 May 2024

CRISM Therapeutics Corporation

(AIM:CRTX)

Admission to Trading and First Day of Dealings

CRISM Therapeutics Corporation ("CRISM" or the "Company"), previously called Amur Minerals Corporation, is pleased to announce that, in conjunction and simultaneously with the completion of the acquisition of the entire issued share capital and other securities of Extruded Pharmaceuticals Limited at 8:00 a.m. today, its ordinary shares will commence trading on AIM under the ticker CRTX, with ISIN VGG042401262 and SEDOL number BS60QF6.

CRISM Therapeutics Corporation is a UK-based pharmaceutical company which has developed an innovative drug delivery technology, ChemoSeed, to improve the clinical performance of cancer treatments for solid tumours through the local delivery of chemotherapy.  ChemoSeed is a polymer the size of a grain of rice, administering irinotecan, a generic drug approved to treat brain cancer and can be implanted directly into a tumour or the resection margin following the removal of a tumour.  ChemoSeed will initially be used to treat high grade gliomas, a brain tumour with no satisfactory treatment.

More information on CRISM Therapeutics Corporation and the Admission Document can be found here: www.crismtherapeutics.com.

The Directors of CRISM consider key strengths to include:

·              Potential for rapid progression to clinical trials, assuming no need for further toxicology trials, which would reduce time to conditional marketing authorisation by six to nine months and direct costs of development by £400,000

·              Based on available animal data, the Tessa Jowell BRAIN MATRIX Scientific Advisory Board has approved the inclusion of ChemoSeed in its Phase II platform clinical trial, which represents an efficient and cost-effective opportunity for clinical development

·              Utilising pre-approved drug, irinotecan, reduces risk profile in clinical trials

·              Attractive end market with the high grade glioma market valued at circa £1.7 billion

·              Target market has orphan disease designation, meaning that ChemoSeed could receive conditional marketing authorisation for high grade glioma in the UK following positive Phase II clinical trials

·              CRISM expects to begin its first clinical trial in late 2025. Should the trial generate positive results, given the unmet need for new treatments, this may enable CRISM to commercialise the product for both sales of ChemoSeed and licensing of the platform technology

·              If ChemoSeed works well in clinical trials, the Board anticipates ChemoSeed may get approval for compassionate use for other solid tumours where surgical resection takes place or there is ease of access to the tumour, such as pancreatic cancer

·              All the necessary intellectual property for ChemoSeed has been assigned to CRISM, which has submitted patent applications in relevant jurisdictions

Board of Directors

CRISM has a strong Board with a combination of expertise in R&D, commercialisation in healthcare and public markets. Biographies of the Board of Directors are below.

CRISM Therapeutics CEO, Andrew Webb commented: "We are delighted to have completed this reverse takeover and to begin CRISM Therapeutics' journey as an AIM quoted company.  We believe CRISM has an attractive risk profile owing to using an existing pre-approved drug, irinotecan, and we have a clear strategy for progressing ChemoSeed through development and to commercialisation with support of organisations such as the Tessa Jowell BRAIN MATRIX.

"Brain tumours remain the biggest cancer killer of children and adults under 40, and there remains a significant lack of cancer research funding in this indication. We hope to change the lives of patients with this condition and believe that ChemoSeed has the potential to become transformational, owing to its novel delivery mechanism, in which we hope to prevent any tumour regrowth.

"CRISM operates in attractive markets, with the high grade glioma market valued at circa £1.7 billion, and other indications with solid tumours providing further potential upside. We are very excited to progress into phase II clinical trials and will keep shareholders up to date with our development. I'd like to thank our shareholders, for their support in this process and we look forward to repaying their faith as we deliver on our objectives look to create value in the process."

Shares in issue and Total Voting Rights

As disclosed in the Company's Admission Document published on 13 May 2024, the Company expected to have 32,678,150 shares in issue at readmission. As a result of the share consolidation and fractional entitlements, the Company has issued a further 162 shares, application for which will be made to be to the London Stock Exchange to be admitted to trading on AIM on or around 7 June 2024 ("Admission"). Following Admission, the total issued share capital of the Company will consist of 32,678,312 Ordinary Shares each with voting rights. The Company does not hold any Ordinary Shares in treasury. Therefore, the total number of voting rights in the Company will be 32,678,312.

Enquiries:

Background

CRISM's lead product, ChemoSeed is a polymer the size of a grain of rice, administering irinotecan, a generic drug approved to treat brain cancer and can be implanted directly into a tumour or the resection margin following the removal of a tumour, thereby ensuring that effective therapeutic concentrations of chemotherapy drugs directly reach the tumour tissue.  This directs that therapeutic concentrations of chemotherapy drugs reach the deep-seated tumour tissue or cover the entire resection margin.

ChemoSeed will initially be used to treat high grade gliomas, a brain tumour with no satisfactory treatment.  In the case of treating high grade gliomas, ChemoSeeds can be implanted during surgery thereby bypassing the blood brain barrier, which prevents other treatments from being able to reach the tumour and be effective.  Brain tumours are the biggest cancer killer of children and adults under the age of 40.  In the UK, approximately 16,000 new cases are diagnosed annually, with an estimated 60,000 people living with the condition. Despite this, just one per cent. of cancer research funding has been allocated to brain tumours since records began in 2002. 

ChemoSeed addresses a significant, unmet medical need in the treatment of high-grade glioma. There are no current cures and present treatments merely seek to extend life, often by just a few months, with serious adverse side effects. Each ChemoSeed consists of the pre-approved chemotherapy drug, irinotecan, and the biodegradable polymer PLGA, both of which have been previously administered to the brain with no toxicity issues. This, combined with the unmet medical needs of the target market for ChemoSeed, means CRISM could potentially receive conditional marketing authorisation in the UK on the back of positive Phase II clinical trial data. This authorisation could be received as early as 2028, therefore reducing the time and cost to commercialisation of irinotecan loaded ChemoSeeds for high-grade glioma and bringing a new treatment to the market for a serious unmet medical need.  CRISM has the opportunity to licence the technology in addition to direct sales.

Should the model work in high-grade glioma, CRISM plans to develop ChemoSeed products for other cancers where a local drug delivery strategy would be of benefit, such as pancreatic, prostate, bladder, breast and liver cancers.

Board of Directors

Dr Nermeen Yunus Varawalla - Independent Non-Executive Chair

Dr Nermeen Varawalla is a healthcare and life sciences business leader, who founded, built and exited a number of multinational start up and corporate businesses. She has deep expertise in clinical development, translational medicine and medical affairs having held executive positions in contract research organisations and biopharmaceutical companies including PRA Health (now ICON plc) and BTG International plc, until its acquisition by Boston Scientific Corporation. Most recently she was Chief Medical Officer at Relief Therapeutics, a listed biopharmaceutical company focused on COVID 19 and rare genetic diseases. In addition, Dr Varawalla has served two terms as a Trustee Board Member for the Malaria Consortium where she was also a member of its Finance, Audit and Risk Committee. Dr Varawalla has trained in clinical medicine at the Universities of Oxford and Mumbai, holds a DPhil (PhD) in Molecular Medicine from Oxford's Institute of Molecular Medicine and an MBA from INSEAD.

Andrew James Webb - Chief Executive Officer

Andrew Webb is an experienced entrepreneur in the biotechnology sector. Mr Webb has over 30 years of commercial experience in the Diagnostics and Life Sciences industry. Prior to Extruded Pharmaceuticals he was Chief Commercial Officer at Novel Technologies Holdings Ltd. Before NTH he was Chief Executive Officer and founder of EKF Molecular Diagnostics and a non-executive director for Arcis Biotechnology. He was previously Senior Director at Qiagen following the acquisition of the personalised healthcare company, DxS Ltd in 2009 where he was Commercial Director. Prior to DxS, Mr Webb was with Amersham Biosciences (now GE Healthcare) and in preclinical research at SmithKlineBeecham (now GlaxoSmithKline).

Dr Christopher ("Chris") McConville - Chief Scientific Officer

Dr McConville is an Associate Professor in Pharmaceutics, Drug Formulation and Delivery at the University of Birmingham as well as the inventor of ChemoSeed. He is an experienced formulation scientist and project manager with expertise in translating research from the lab to the clinic. He has taken a number of pharmaceutical innovations from R&D to the clinic and is currently seconded as Director of Translation to the PHTA (Precision Health Technology Accelerator), a University of Birmingham initiative dedicated to the rapid development and translation of innovative therapies and technologies from concept to clinical evaluation.  Dr McConville is responsible for establishing the translational and commercialisation pathway for novel technologies, identifying the key partners needed to advance the technology onto commercialisation and then build and lead the team to ensure the translational and commercialisation pathway is followed and goals and targets achieved on time.

Gerald ("Gerry") Douglas Beaney - Independent Non-Executive Director

Gerry is a consultant to growth companies seeking strategic advice or funding for expansion.

He was a non-executive director of Spectral MD Holdings Ltd (subsequently renamed Spectral AI, Inc.) a medical technology company quoted on AIM between June 2021 and September 2023. He acted as chairman of the Nomination Committee and was a member of the audit committee. He was formerly chairman of the remuneration committee. Gerry stepped down from the board on the company's admission to NASDAQ in September 2023.

Prior to Spectral MD Holdings Ltd, he carried out senior executive roles in the corporate finance sector for over 25 years. During 2018 he was the Chief Executive Officer of Northland Capital Partners Limited, an institutional stockbroker based in London. He acted as Northland's Head of Corporate Finance between 2014 and 2018. From 1997 to 2013 he was a Partner and Head of Capital Markets at Grant Thornton UK LLP which grew to become the largest independent nominated adviser to AIM companies under his leadership. Prior to 1997 Gerry held various roles with Grant Thornton in the UK and New York City. He is a member of the Institute of Chartered Accountants of Scotland and was a member of the American Institute of Certified Public Accountants between 1991 and 2016. He holds a Bachelor of Accountancy Degree from the University of Glasgow.